Biotech Alert: Searches spiking for these stocks today

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include: 

• CytomX Therapeutics (CTMX), 17,900% surge in interest
• Cyclacel Pharmaceuticals (CYCC), 662% surge in interest
• TG Therapeutics (TGTX), 385% surge in interest
• Daré Bioscience (DARE), 337% surge in interest
• Aptevo Therapeutics (APVO), 269% surge in interest
• BIO-TECHNE (TECH), 260% surge in interest
• Apellis Pharmaceuticals (APLS), 252% surge in interest
• Emergent BioSolutions (EBS), 248% surge in interest
• Amarin (AMRN), 218% surge in interest
• Voyager Therapeutics (VYGR), 195% surge in interest

Pipeline and key clinical candidates for these companies:

CytomX is a clinical-stage, oncology-focused biopharmaceutical company whose pipeline comprises seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates, or “ADCs,” T-cell engaging bispecific antibodies, or “TCBs,” and immune modulators such as cytokines and checkpoint inhibitors. CX-2029 is an investigational conditionally activated antibody-drug conjugate directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie (ABBV). CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb (BMY), as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen (AMGN).

Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation, epigenetics and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the epigenetic/anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel’s strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications.

TG Therapeutics is focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the FDA for Briumvi, for the treatment of adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Daré Bioscience is advancing products for women’s health, stating that the company’s mission is “to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.” Daré’s first FDA-approved product, XACIATO vaginal gel, is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause.

Aptevo Therapeutics is focused on developing novel immunotherapies for the treatment of cancer. APVO436 is a bispecific CD3xCD123 ADAPTIR currently in Phase 1b development in a multi-center, multi-cohort trial designed to evaluate safety, tolerability and efficacy in combination therapy and monotherapy for patients with acute myeloid leukemia, or AML. The company plans to initiate a Phase 2 trial, evaluating APVO436 in combination with venetoclax and azacitidine in patients with AML who are venetoclax treatment naive, in 2H23.

Bio-Techne is a developer and manufacturer of purified proteins and reagent solutions – notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, T-Cell activation and gene editing technologies. Bio-Techne’s product portfolio also includes protein analysis solutions, sold under the ProteinSimple brand name.

Apellis Pharmaceuticals says the company “ushered in the first new class of complement medicine in 15 years” with the approval of the first and only targeted C3 therapy. Apellis is advancing this science to “continually develop transformative medicines for people living with rare, retinal, and neurological diseases,” it stated.

Emergent BioSolutions provides solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that the company develops and manufactures for governments and consumers. Emergent also offers a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.

Amarin is an “innovative pharmaceutical company leading a new paradigm in cardiovascular disease management” and is “committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide.”

Voyager Therapeutics says its TRACER AAV capsid discovery platform has “generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors.” The platform is fueling alliances with Pfizer (PFE), Novartis (NVS) and Neurocrine Biosciences (NBIX) as well as multiple programs in Voyager’s own pipeline, which includes wholly-owned and collaborative preclinical programs in Alzheimer’s disease, amyotrophic lateral sclerosis, Parkinson’s disease, and Friedreich’s Ataxia, the company has stated.

Recent news on these stocks:

May 1

BMO Capital noted that in a “surprise announcement,” CytomX Therapeutics this morning announced it will provide an initial CX-904 Phase 1a dose escalation update when it reports Q1 results on May 8. CytomX had previously guided to CX-904 initial Phase 1a data in solid tumors in the second half of 2024, the analyst tells investors in a research note. The firm said the Phase 1a data is intended to inform a potential decision to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types in conjunction with partner Amgen (AMGN). BMO expects the stock to react positively “given current levels” to the announcement. It has a Market Perform rating on CytomX with a $3.25 price target.

TG Therapeutics reported Q1 EPS (7c) against a consensus of (4c), and reported Q1 revenue $63.474M against a consensus of $54.58M. Michael Weiss, CEO, stated, “We were extremely pleased with the strong sales of just over $50M in BRIUMVI U.S. net revenue for the first quarter of 2024, which was ahead of our guidance. We believe this strong momentum will continue to build throughout 2024 and are pleased to update our yearly guidance to $270M to $290M in BRIUMVI U.S. net revenue in 2024.” Weiss continued, “We are also pleased to be making strides towards our clinical goals for the year which include enhancing the convenient dosing of IV BRIUMVI, developing a subcutaneous form of BRIUMVI, moving BRIUMVI into additional indications beyond MS, and advancing our recent pipeline addition, azer-cel, an allogeneic CAR T, into clinical development.”

Bio-Techne reported Q3 adjusted EPS 48c against a consensus of 45c, and reported Q3 revenue $303.43M against a consensus of $292.19M. “I am proud of the remarkable execution of our Bio-Techne team under challenging end market conditions, which drove solid top-line performance,” said Kim Kelderman, CEO of Bio-Techne. “As expected, we experienced subsiding headwinds from de-stocking but also delivered year-over-year growth in a depressed biopharma end market. This top-line performance, combined with the benefits of cost and efficiency initiatives, resulted in a 33.0% adjusted operating margin, representing a 290 basis-point sequential improvement.”

Emergent BioSolutions reported Q1 EPS 59c vs. ($3.26) last year, and reported Q1 revenue $300.4M vs. $164.3M last year. “We delivered a strong quarter with growth across all our key products,” said Joe Papa, CEO at Emergent. “We also took significant actions to improve our debt position, reduce operating expenses and strengthen our financial flexibility. Emergent’s transformation will not happen overnight. The actions we are implementing today, combined with the assets Emergent possesses, will enable us to move faster, reach farther and be more nimble. The public health threats we collectively face are changing, and so is Emergent.”

Emergent BioSolutions announced the next phase of its new operational plan that consolidates operations, closes several manufacturing facilities, and restructures its enterprise workforce. Emergent will continue to focus on its core products business – medical countermeasures and Narcan Nasal Spray -and on delivering for its patients and customers, including the U.S. and allied governments. These strategic actions will lead to a reduction of approximately 300 employees across all areas of the company, and the elimination of approximately 85 positions that are currently vacant. In combination with other rationalizing initiatives, these actions are expected to result in annualized savings of approximately $80M when fully implemented. The costs associated with the restructuring plan are estimated to be approximately $18M-$21M and are expected to be primarily incurred in the second half of 2024. As part of the operational changes, Emergent will shut down both its Baltimore-Bayview Drug Substance manufacturing facility and Rockville, Maryland Drug Product facility. Emergent will concentrate operations at sites in Winnipeg, Canada, and Lansing, Michigan, while the company actively explores strategic alternatives for its other sites throughout the year. As part of the reorganization, a new chief science officer role has been created and added to the executive management team, reporting to Papa.

Amarin reported Q1 EPS (1c) against a consensus of (3c), and reported Q1 revenue $55.156M against a consensus of $57.04M. “Our team continued to make progress across aspects of our business in the first quarter of 2024. In Europe, we successfully secured patent protection extending our intellectual property until 2039, which enhances the value of the business. Our team in Europe delivered ~65% in-market sales growth in the first quarter 2024 versus fourth quarter 2023, led by double-digit percentage increases in patients on therapy in Spain and the U.K., and continued to advance pricing and reimbursement efforts. In the U.S., a genericized market, revenues declined 41% versus first quarter 2023, primarily driven by net selling price due to generic competition. However, as a result of our IPE market leadership and prudent expense management, the U.S. business delivered significant profit which funds our operations in Europe and supports our cash position. In addition, our partnerships across Rest of World are advancing. Finally, we secured shareholder approval for our share repurchase program, and we expect share repurchases to begin following UK High Court approval in the second quarter,” said Patrick Holt, CEO of Amarin. “Overall, we are encouraged by the progress we have made in the first quarter, we remain confident in the business and are focused on enhancing the value of Amarin for the future.”

April 30

Cyclacel Pharmaceuticals entered into definitive agreements for the purchase and sale of an aggregate of 4.97M shares of common stock, series A warrants to purchase up to 4.97M shares of common stock and short-term series B warrants to purchase up to 4.97M shares of common stock at a purchase price of $1.61 per share of common stock and accompanying warrants in a private placement priced at-the-market under Nasdaq rules. The series A warrants and short-term series B warrants will have an exercise price of $1.36 per share and will be exercisable immediately upon issuance. The series A warrants will expire five and one-half years from the date of issuance and the short-term series B warrants will expire eighteen months from the date of issuance. The private placement is expected to close on or about May 2, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds from the offering are expected to be approximately $8M, prior to deducting placement agent’s fees and other offering expenses payable by the company. The company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

XOMA (XOMA) has acquired an economic interest in three women’s health assets – XACIATO vaginal gel 2%, Ovaprene and Sildenafil Cream, 3.6% – from Dare Bioscience, for an upfront payment of $22M. XACIATO is approved by the FDA for the treatment of bacterial vaginosis in females 12 years of age and older. In 2022, Dare entered into a license agreement with Organon, which initiated XACIATO commercial marketing activities in the fourth quarter of 2023. Under the terms of the agreement, XOMA will receive the remaining royalties related to XACIATO not already included in Dare’s December 2023 royalty-backed financing agreement, which equates to low to high single-digit royalties on net sales. XOMA also is entitled to potential milestone payments based on the commercial success of XACIATO. Additionally, XOMA has acquired an interest in a potential milestone and a low single-digit synthetic royalty on Ovaprene, as well as a low single-digit synthetic royalty on Sildenafil Cream, 3.6%. Upon achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Dare.

Jefferies noted that Apellis shares are down due to comments on the FDA having released updated FAERS data as of March 31, but the firm’s view on retinal vasculitis cases remains unchanged, as it had noted last week after its database update. The firm, which notes the two deaths in the FAERS data were not related to Syfovre and said regarding RV cases that only four of them actually occurred in Q1, also advises that investors “keep in mind cases reported by the FDA are not adjudicated.” Jefferies has a Buy rating and $80 price target on Apellis.

Hear more from InvestingChannel by signing up for The Spill.

About “Biotech Alert”

The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.

This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.

This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.